Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Keratome, Ac-Powered
510(k) Number K980508
Device Name KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
Applicant
MICROSPECIALTIES, INC.
16 HIGGINS DR.
MILFORD,  CT  06460
Applicant Contact CHARLES VASSALLO
Correspondent
MICROSPECIALTIES, INC.
16 HIGGINS DR.
MILFORD,  CT  06460
Correspondent Contact CHARLES VASSALLO
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/10/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-